COVID-19 Stress SyndromePhase 1NCT05839236
COVID-19 Vaccination Detoxification in LDL-C
A Phase 1 study testing Atorvastatin Calcium Tablets in people with COVID-19 Stress Syndrome and COVID-19 Vaccine Adverse Reaction, run by Yang I. Pachankis at 1 site in China.
Trial summary
The study hypothesizes that SARS-CoV-2 vaccination poisoning hibernates in human host in Low Density Lipoprotein Cholesterol (LDL-C). The clinical trial is a follow-up from the intervention trial with NCT number NCT05711810. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Stress Syndrome, COVID-19 Vaccine Adverse Reaction, COVID-19-Associated Thromboembolism
- What is being tested?
- Atorvastatin Calcium Tablets
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who received COVID-19 vaccinations, or experiencing long-COVID.
Who cannot join
- People with moderate and severe liver dysfunctions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Vaccination Detoxication in Low Density Lipoprotein Cholesterol
The study hypothesizes that SARS-CoV-2 vaccination poisoning hibernates in human host in Low Density Lipoprotein Cholesterol (LDL-C). The clinical trial is a follow-up from the intervention trial with NCT number NCT05711810. It tests the use of Atorvastatin Calcium Tablets for detoxification and prevention of blood acidification, and the use of the Chinese herb compounded Anti-Viral Granules for the detoxification in the endocrine system.
- Conditions
- COVID-19 Stress Syndrome, COVID-19 Vaccine Adverse Reaction, COVID-19-Associated Thromboembolism, COVID-19 Post-Intensive Care Syndrome, COVID-19-Associated Stroke, COVID-19 Respiratory Infection
- Being tested
- Atorvastatin Calcium Tablets
- Keywords
- COVID-19, SARS-CoV-2, Low Density Lipoprotein Cholesterol, sebum, immune reflex, immunology, immune deficiency, immune regulation, detoxification
- Medical subject headings
- COVID-19 stress syndrome, COVID-19 post-intensive care syndrome, COVID-19, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin Calcium TabletsCombination product
Also called Anti-Viral Granules
The intervention observes the effects of the medicines on the participant's health without the continued interventions on blood pressure. Rescue medicines will be used once if the blood pressure rise again beyond the healthy range.
| Study group | Role | What they receive |
|---|---|---|
| LDL-C Detox | Experimental | The participant is continued from the trial NCT05711810. The follow-up study is separately registered for the etiological evidence from vaccine poisoning.
With the prior study's angiotensin-converting enzyme receptor inhibition therapy reaching desired power level and outcome, the participant's blood pressure. has dropped to normal range in a steady state without signs of sudden death risks.
The separate study defines the treatment medicines in NCT05711810 as rescue medicines for discretions, and experiments with Atorvastatin Calcium Tablets with 20 mg per day, and Chinese herb compounded Anti-Viral Granules 12 g (total) in 3 times per day.
The main ingredients for Anti-Viral Granules are the roots of Isatis indigotica L., Forsythia suspensa, Gypsum, Common Anemarrhena, Reed Rhizome, Rehmannia glutinosa, Patchouli, Tatarinow Sweerflag Rhizome, and Curcuma aromatica. They're mixed with dextrin, Sodium cyclamate, patchouli oil, peppermint oil, and angelica dahurica tincture. Receives: Combination Product: Atorvastatin Calcium Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that total cholesterol levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines with the degeneration of lipids.
Measured: 30 days
Triglycerides Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that triglycerides levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines.
Measured: 30 days
HDL-C Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
LDL-C Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that SARS-CoV-2 hibernating viruses and viral proteins are hidden in the LDL-C.
Measured: 30 days
Apolipoprotein A-I Change
Measured: 30 days
Apolipoproteina B Change
Measured: 30 days
Lipopoliproteina (a) Change
Measured: 30 days
Eosinophil Absolute Number Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Eosinophil Percentage Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Basophil Absolute Number Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Basophil Percentage Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Mean Corpuscular Volume Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Mean Corpuscular Hemoglobin Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Mean Corpuscular Hemoglobin Concentration Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Red cell Distribution Width Coefficient of Variation Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Red cell Distribution Width Standard Deviation Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Plateletcrit Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Platelet Distribution Width Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Mean Platelet Volume Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Measured: 30 days
Secondary outcomes (3)
Heart Rate Change
The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic \& Diastolic Blood Pressure and heart rate as incremented. Heart rate variance indicates to immune responses.
Measured: 4 hours
Systolic Blood Pressure Change
The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic \& Diastolic Blood Pressure and heart rate as incremented. SBP variance indicates to infection activities.
Measured: 4 hours
Diastolic Blood Pressure Change
The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic \& Diastolic Blood Pressure and heart rate as incremented. DBP variance indicates to immune attack activities.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 May 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Stress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang I. Pachankis
- Responsible party
- Sponsor-investigator, Yang I. Pachankis, Pachankis, Yang I., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839236
- Sponsor's protocol ID
- SARSCoVVAXDetox
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected will be deidentified and shared on Zenodo with the same entry currently assigned the doi: 10.5281/zenodo.7856000.
Publications
Smith KR, Thiboutot DM. Thematic review series: skin lipids. Sebaceous gland lipids: friend or foe? J Lipid Res. 2008 Feb;49(2):271-81. doi: 10.1194/jlr.R700015-JLR200. Epub 2007 Nov 1.
PubMed 17975220Lovaszi M, Szegedi A, Zouboulis CC, Torocsik D. Sebaceous-immunobiology is orchestrated by sebum lipids. Dermatoendocrinol. 2017 Oct 17;9(1):e1375636. doi: 10.1080/19381980.2017.1375636. eCollection 2017.
PubMed 29484100Zouboulis CC, Coenye T, He L, Kabashima K, Kobayashi T, Niemann C, Nomura T, Olah A, Picardo M, Quist SR, Sasano H, Schneider MR, Torocsik D, Wong SY. Sebaceous immunobiology - skin homeostasis, pathophysiology, coordination of innate immunity and inflammatory response and disease associations. Front Immunol. 2022 Nov 10;13:1029818. doi: 10.3389/fimmu.2022.1029818. eCollection 2022.
PubMed 36439142Sorgato MC, Ferguson SJ, Kell DB, John P. The protonmotive force in bovine heart submitochondrial particles. Magnitude, sites of generation and comparison with the phosphorylation potential. Biochem J. 1978 Jul 15;174(1):237-56. doi: 10.1042/bj1740237.
PubMed 212021EVANS MC. THE PHOTO-OXIDATION OF SUCCINATE BY CHROMATOPHORES OF RHODOSPIRILLUM RUBRUM. Biochem J. 1965 Jun;95(3):661-8. doi: 10.1042/bj0950661.
PubMed 14342500Mackey K, Ayers CK, Kondo KK, Saha S, Advani SM, Young S, Spencer H, Rusek M, Anderson J, Veazie S, Smith M, Kansagara D. Racial and Ethnic Disparities in COVID-19-Related Infections, Hospitalizations, and Deaths : A Systematic Review. Ann Intern Med. 2021 Mar;174(3):362-373. doi: 10.7326/M20-6306. Epub 2020 Dec 1.
PubMed 33253040Mathur R, Rentsch CT, Morton CE, Hulme WJ, Schultze A, MacKenna B, Eggo RM, Bhaskaran K, Wong AYS, Williamson EJ, Forbes H, Wing K, McDonald HI, Bates C, Bacon S, Walker AJ, Evans D, Inglesby P, Mehrkar A, Curtis HJ, DeVito NJ, Croker R, Drysdale H, Cockburn J, Parry J, Hester F, Harper S, Douglas IJ, Tomlinson L, Evans SJW, Grieve R, Harrison D, Rowan K, Khunti K, Chaturvedi N, Smeeth L, Goldacre B; OpenSAFELY Collaborative. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform. Lancet. 2021 May 8;397(10286):1711-1724. doi: 10.1016/S0140-6736(21)00634-6. Epub 2021 Apr 30.
PubMed 33939953Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.
PubMed 34124081Knox PP, Lukashev EP, Korvatovskii BN, Seifullina NK, Goryachev SN, Allakhverdiev ES, Paschenko VZ. Effect of Dipyridamole on Membrane Energization and Energy Transfer in Chromatophores of Rba. sphaeroides. Biochemistry (Mosc). 2022 Oct;87(10):1138-1148. doi: 10.1134/S0006297922100078.
PubMed 36273882DE Flora S, Balansky R, LA Maestra S. Antioxidants and COVID-19. J Prev Med Hyg. 2021 Jun 5;62(1 Suppl 3):E34-E45. doi: 10.15167/2421-4248/jpmh2021.62.1S3.1895. eCollection 2021 Mar. Italian.
PubMed 34622082Seneff S, Kyriakopoulos AM, Nigh G, McCullough PA. A Potential Role of the Spike Protein in Neurodegenerative Diseases: A Narrative Review. Cureus. 2023 Feb 11;15(2):e34872. doi: 10.7759/cureus.34872. eCollection 2023 Feb.
PubMed 36788995Salih RQ, Salih GA, Abdulla BA, Ahmed AD, Mohammed HR, Kakamad FH, Salih AM. False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Ann Med Surg (Lond). 2021 Nov;71:103027. doi: 10.1016/j.amsu.2021.103027. Epub 2021 Nov 6.
PubMed 34777794Yang IP. Theoretical Strategies in SARS-CoV-2 Human Host Treatment. Journal of Clinical and Medical Images. 2023; 6(28).
Yang IP. Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks. Biomedical Science and Clinical Research. 2023; 2(1): 86-93.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccination Detoxication in Low Density Lipoprotein Cholesterol
- ClinicalTrials.gov ID
- NCT05839236
- Acronym / sponsor ID
- SARSCoVVAXDetox
- Conditions
- COVID-19 Stress Syndrome, COVID-19 Vaccine Adverse Reaction, COVID-19-Associated Thromboembolism, COVID-19 Post-Intensive Care Syndrome, COVID-19-Associated Stroke, COVID-19 Respiratory Infection
- Keywords
- COVID-19, SARS-CoV-2, Low Density Lipoprotein Cholesterol, sebum, immune reflex, immunology, immune deficiency, immune regulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yang I. Pachankis
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesizes that SARS-CoV-2 vaccination poisoning hibernates in human host in Low Density Lipoprotein Cholesterol (LDL-C). The clinical trial is a follow-up from the intervention trial with NCT number NCT05711810. It tests the use of Atorvastatin Calcium Tablets for detoxification and prevention of blood acidification, and the use of the Chinese herb compounded Anti-Viral Granules for the detoxification in the endocrine system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDL-C Detox | Experimental | Combination Product: Atorvastatin Calcium TabletsThe participant is continued from the trial NCT05711810. The follow-up study is separately registered for the etiological evidence from vaccine poisoning. With the prior study's angiotensin-converting enzyme receptor inhibition therapy reaching desired power level and outcome, the participant's blood pressure. has dropped to normal range in a steady state without signs of sudden death risks. The separate study defines the treatment medicines in NCT05711810 as rescue medicines for discretions, and experiments with Atorvastatin Calcium Tablets with 20 mg per day, and Chinese herb compounded Anti-Viral Granules 12 g (total) in 3 times per day. The main ingredients for Anti-Viral Granules are the roots of Isatis indigotica L., Forsythia suspensa, Gypsum, Common Anemarrhena, Reed Rhizome, Rehmannia glutinosa, Patchouli, Tatarinow Sweerflag Rhizome, and Curcuma aromatica. They're mixed with dextrin, Sodium cyclamate, patchouli oil, peppermint oil, and angelica dahurica tincture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who received COVID-19 vaccinations, or experiencing long-COVID.
Key exclusion criteria (1 listed)
- People with moderate and severe liver dysfunctions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin Calcium TabletsAlso: Anti-Viral GranulesThe intervention observes the effects of the medicines on the participant's health without the continued interventions on blood pressure. Rescue medicines will be used once if the blood pressure rise again beyond the healthy range. | Combination product | LDL-C Detox |
Primary outcome
Total Cholesterol Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that total cholesterol levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines with the degeneration of lipids.
Triglycerides Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that triglycerides levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines.
HDL-C Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
LDL-C Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that SARS-CoV-2 hibernating viruses and viral proteins are hidden in the LDL-C.
Apolipoprotein A-I Change
Time frame: 30 days
Apolipoproteina B Change
Time frame: 30 days
Lipopoliproteina (a) Change
Time frame: 30 days
Eosinophil Absolute Number Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Eosinophil Percentage Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Basophil Absolute Number Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Basophil Percentage Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Volume Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Hemoglobin Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Hemoglobin Concentration Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Red cell Distribution Width Coefficient of Variation Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Red cell Distribution Width Standard Deviation Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Plateletcrit Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Platelet Distribution Width Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Platelet Volume Change
Time frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
3 secondary outcomes
Heart Rate Change
Time frame: 4 hours
Systolic Blood Pressure Change
Time frame: 4 hours
Diastolic Blood Pressure Change
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 17975220Smith KR, Thiboutot DM. Thematic review series: skin lipids. Sebaceous gland lipids: friend or foe? J Lipid Res. 2008 Feb;49(2):271-81. doi: 10.1194/jlr.R700015-JLR200. Epub 2007 Nov 1.
- Background: PubMed 29484100Lovaszi M, Szegedi A, Zouboulis CC, Torocsik D. Sebaceous-immunobiology is orchestrated by sebum lipids. Dermatoendocrinol. 2017 Oct 17;9(1):e1375636. doi: 10.1080/19381980.2017.1375636. eCollection 2017.
- Background: PubMed 36439142Zouboulis CC, Coenye T, He L, Kabashima K, Kobayashi T, Niemann C, Nomura T, Olah A, Picardo M, Quist SR, Sasano H, Schneider MR, Torocsik D, Wong SY. Sebaceous immunobiology - skin homeostasis, pathophysiology, coordination of innate immunity and inflammatory response and disease associations. Front Immunol. 2022 Nov 10;13:1029818. doi: 10.3389/fimmu.2022.1029818. eCollection 2022.
- Background: PubMed 212021Sorgato MC, Ferguson SJ, Kell DB, John P. The protonmotive force in bovine heart submitochondrial particles. Magnitude, sites of generation and comparison with the phosphorylation potential. Biochem J. 1978 Jul 15;174(1):237-56. doi: 10.1042/bj1740237.
- Background: PubMed 14342500EVANS MC. THE PHOTO-OXIDATION OF SUCCINATE BY CHROMATOPHORES OF RHODOSPIRILLUM RUBRUM. Biochem J. 1965 Jun;95(3):661-8. doi: 10.1042/bj0950661.
- Background: PubMed 33253040Mackey K, Ayers CK, Kondo KK, Saha S, Advani SM, Young S, Spencer H, Rusek M, Anderson J, Veazie S, Smith M, Kansagara D. Racial and Ethnic Disparities in COVID-19-Related Infections, Hospitalizations, and Deaths : A Systematic Review. Ann Intern Med. 2021 Mar;174(3):362-373. doi: 10.7326/M20-6306. Epub 2020 Dec 1.
- Background: PubMed 33939953Mathur R, Rentsch CT, Morton CE, Hulme WJ, Schultze A, MacKenna B, Eggo RM, Bhaskaran K, Wong AYS, Williamson EJ, Forbes H, Wing K, McDonald HI, Bates C, Bacon S, Walker AJ, Evans D, Inglesby P, Mehrkar A, Curtis HJ, DeVito NJ, Croker R, Drysdale H, Cockburn J, Parry J, Hester F, Harper S, Douglas IJ, Tomlinson L, Evans SJW, Grieve R, Harrison D, Rowan K, Khunti K, Chaturvedi N, Smeeth L, Goldacre B; OpenSAFELY Collaborative. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform. Lancet. 2021 May 8;397(10286):1711-1724. doi: 10.1016/S0140-6736(21)00634-6. Epub 2021 Apr 30.
- Background: PubMed 34124081Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.
- Background: PubMed 36273882Knox PP, Lukashev EP, Korvatovskii BN, Seifullina NK, Goryachev SN, Allakhverdiev ES, Paschenko VZ. Effect of Dipyridamole on Membrane Energization and Energy Transfer in Chromatophores of Rba. sphaeroides. Biochemistry (Mosc). 2022 Oct;87(10):1138-1148. doi: 10.1134/S0006297922100078.
- Background: PubMed 34622082DE Flora S, Balansky R, LA Maestra S. Antioxidants and COVID-19. J Prev Med Hyg. 2021 Jun 5;62(1 Suppl 3):E34-E45. doi: 10.15167/2421-4248/jpmh2021.62.1S3.1895. eCollection 2021 Mar. Italian.
- Background: PubMed 36788995Seneff S, Kyriakopoulos AM, Nigh G, McCullough PA. A Potential Role of the Spike Protein in Neurodegenerative Diseases: A Narrative Review. Cureus. 2023 Feb 11;15(2):e34872. doi: 10.7759/cureus.34872. eCollection 2023 Feb.
- Background: PubMed 34777794Salih RQ, Salih GA, Abdulla BA, Ahmed AD, Mohammed HR, Kakamad FH, Salih AM. False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Ann Med Surg (Lond). 2021 Nov;71:103027. doi: 10.1016/j.amsu.2021.103027. Epub 2021 Nov 6.
- Individual participant dataSharing planned: Yes. The data collected will be deidentified and shared on Zenodo with the same entry currently assigned the doi: 10.5281/zenodo.7856000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin Calcium Tablets in people with COVID-19 Stress Syndrome and COVID-19 Vaccine Adverse Reaction, run by Yang I. Pachankis at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol Change (time frame: 30 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839236, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.